FDA 510(k)

EFAI ChestSuite XR Pneumothorax Assessment System

Número K: K221552 · 2022-11-08

Data da decisão2022-11-08

Código do produtoQFM

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EFAI ChestSuite XR Pneumothorax Assessment System is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2022-11-08 under 510(k) number K221552. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EFAI ChestSuite XR Pneumothorax Assessment System?

EFAI ChestSuite XR Pneumothorax Assessment System is a medical device that received FDA 510(k) clearance on 2022-11-08. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K221552.

When did EFAI ChestSuite XR Pneumothorax Assessment System receive FDA 510(k) clearance?

EFAI ChestSuite XR Pneumothorax Assessment System received FDA 510(k) clearance on 2022-11-08, under 510(k) number K221552.

Who is the listed applicant for EFAI ChestSuite XR Pneumothorax Assessment System?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EFAI ChestSuite XR Pneumothorax Assessment System?

The FDA product code for EFAI ChestSuite XR Pneumothorax Assessment System is QFM.

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Fonte oficial

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